HandPICO Fractional Laser Handpiece Tip
K-Number: K242534 · 2024-12-20
ApplicantVydence Medical
Decision Date2024-12-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
HandPICO Fractional Laser Handpiece Tip is a medical device manufactured by Vydence Medical. It received FDA 510(k) clearance on 2024-12-20 under approval number K242534. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the HandPICO Fractional Laser Handpiece Tip?
HandPICO Fractional Laser Handpiece Tip is a medical device that received FDA 510(k) clearance on 2024-12-20. It is manufactured by Vydence Medical. The 510(k) number is K242534.
When was HandPICO Fractional Laser Handpiece Tip approved by the FDA?
HandPICO Fractional Laser Handpiece Tip received FDA 510(k) clearance on 2024-12-20, under approval number K242534.
What company makes HandPICO Fractional Laser Handpiece Tip?
HandPICO Fractional Laser Handpiece Tip is manufactured by Vydence Medical.
What is the FDA product code for HandPICO Fractional Laser Handpiece Tip?
The FDA product code for HandPICO Fractional Laser Handpiece Tip is GEX. This falls under the Gastroenterology category.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.